Clinical Implications of Fetal Positioning During Delivery

• Conditions: Fetal Position and Presentation Abnormalities

• Registration Number: NCT04813237
• Lead Sponsor: Żelazna Medical Centre, LLC

Brief Summary

The project aims to find a relationship between the positioning of the foetus before and during birth and the results of obstetrics and to determine their incidence in the Polish population. The study will be conducted by combining the use of ultrasound diagnostics, midwives observations during childbirth, analysis of medical documentation and a questionnaire on the activity of examined women. The obtained results will be used to prepare guidelines for the birth in a particular foetus position.

Detailed Description

The purpose of the examination is to describe the difficulties associated with delivery in a non-optimal position of the fetus. Initial observations show that such childbirth is perceived as difficult by both the women giving birth and the staff. The aim of the study is to describe the level of difficulty of this labor, expressed as the experience of the woman, as well as all the elements that may affect the difficulty of this labor, for example, slower or no progress in labor, disturbances in systolic function, injuries, the need to use epidural anesthesia, increased blood loss.

Study Timeline

• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-24
• Study Start: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• during childbirth,
• in a single pregnancy,

Exclusion Criteria

• pelvic position of the fetus
• in whom labor is induced for reasons other than post-term pregnancy,
• women who came to the hospital in the second stage of labor
• severe diseases mother or foetus.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mode of delivery	immediately after delivery	Mode of delivery as measured by number of women who had a vaginal, instrumental or operational delivery.

Secondary Outcome Measures

Name	Time	Method
Blood loss	immediately after delivery	postpartum blood loss (ml)
Difficulty of childbirth	immediately after delivery	difficulty of childbirth as measured by subjective assessment of the woman and the midwife
Duration of delivery	immediately after birth	the time of 1,2,3 and 4 stage of labor
Uterine contractions	during birth	uterine contractions as measured by number of contractions and assessment of uterine contractile coordination
Labor progress	during birth	Labor progress as measured by assessment of the head insertion, advancement in the birth canal,
Epidural	immediately after delivery	as measured by epidural or not
Perineum injury	immediately after delivery	as measured by number and extent of injury
Episiotomy	immediately after delivery	as measured by episiotomy or not
Methods of placental separation	immediately after delivery	as measured by number of Duncan or SchultZ methods

Trial Locations

Locations (1)

Żelazna Medical Centre, LLC; 🇵🇱 Warsaw, Mazowieckie, Poland